Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States.

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

Activated clotting time in inpatient diagnostic and interventional settings.

Monitoring for the anticoagulant effect of unfractionated (UFH) at the point of care using activated clotting time in real time is vital where risk of thrombosis is high. Although monitoring UFH effect is a routine and important task, changing from one ACT instrument type or technology to another must be preceded by a clinical and statistical evaluation to determine the suitability and repeatability and establish normal and treatable ranges of this newer instrument. In this multi-center prospective evaluation we tested 1236 paired ACT+ samples, and 463 paired ACT-LR samples (1699 total) from enrolled study subjects. Clinical settings included CVOR cardiopulmonary bypass, at the beside in extracorporeal life support (ELS), the Cardiac Catheterization Lab (CCL) during diagnostic studies and percutaneous coronary interventions (PCI), interventional radiology procedures and EP interventions. This study found more consistent clinical performance from the GEM Hemochron 100 as compared to the current clinical model, the Hemochron Signature Elite. The bias of GEM Hemochron 100 for ACT+ and ACT-LR was greatest in the setting of the CVOR where ACT levels were high. ACT-LR measurements by the GEM Hemochron 100 were comparable to the SE when performed in settings of CCL, ECM, EP and ICU. Results obtained for both ACT-LR and ACT+ in all clinical settings in this study using the GEM Hemochron 100 are as accurate and more repeatable as those with the current clinically available Signature Elite.

The medically managed patient with severe symptomatic aortic stenosis in the TAVR era: Patient characteristics, reasons for medical management, and quality of shared decision making at heart valve treatment centers.

BACKGROUND: Little is known about patients with severe symptomatic aortic stenosis (AS) who receive medical management despite evaluation at a heart valve treatment center. OBJECTIVE: We identified patient characteristics associated with medical management, physician-reported reasons for selecting medical management, and patients' perceptions of their involvement and satisfaction with treatment selection. METHODS AND RESULTS: Of 454 patients evaluated for AS at 9 established heart valve treatment centers from December 12, 2013 to August 19, 2014, we included 407 with severe symptomatic AS. Information was collected using medical record review and survey of patients and treating physicians. Of 407 patients, 212 received transcatheter aortic valve replacement (TAVR), 124 received surgical aortic valve replacement (SAVR), and 71 received medical management (no SAVR/TAVR). Thirty-day predicted mortality was higher in patients receiving TAVR (8.7%) or medical management (9.8%) compared with SAVR (3.4%) (P<0.001). Physician-reported reasons for medical management included patient preference (31.0%), medical futility (19.7%), inoperability/anatomic infeasibility (11.3%), and inadequate vascular access (8.5%). Compared with patients receiving AVR, medically managed patients were less likely to report that they received enough information about the pros and cons of treatment options (P = 0.03), that their physicians involved them in treatment decisions (P<0.001), and that final decisions were the right ones (P<0.001). CONCLUSIONS: Patient preference was the most common physician-reported reason for selecting non-invasive AS management, yet patients not undergoing AVR after valve center evaluation reported being less likely to receive sufficient education about treatment options and more likely to feel uncertain about final treatment decisions. Greater attention to shared decision making may improve the experience of care for this vulnerable group of patients.

Comparison of Two Risk Models in Predicting the Incidence of Contrast-Induced Nephropathy after Percutaneous Coronary Intervention.

OBJECTIVES: We sought to compare 2 contrast-induced nephropathy (CIN) risk prediction models in a validation cohort using a consensus definition. BACKGROUND: Contrast-induced nephropathy (CIN) is independently associated with mortality following percutaneous coronary intervention (PCI). Multiple prediction models for the development of CIN have been published using heterogeneous outcome definitions. METHODS: We analyzed 5,540 patients who underwent PCI from January 2005 to June 2012 at a single academic medical center. The primary outcome was development of CIN, defined as an increase in serum creatinine of ≥0.5 mg/dl or a relative increase of ≥25% from baseline. Receiver operator characteristic (ROC) curves were used to evaluate the discriminatory power of Mehran and WBH prediction models. RESULTS: The mean age of our cohort was 68 ± 12 years. The mean baseline creatinine was 1.2 ± 0.53 mg/dl (eGFR 73 ± 27 ml/min). The mean contrast volume used was 212 ± 92 ml. CIN occurred in 436 patients (7.9%). The Mehran risk score demonstrated better discrimination than the William Beaumont Hospital (WBH) risk score to predict the occurrence of CIN (c statistic: 0.82 vs. 0.73, respectively). Mortality at 30 days was approximately 8 times higher among patients with CIN as compared to those without (14.7% vs. 1.8% P < 0.01). CONCLUSIONS: In an independent validation cohort, the Mehran risk model demonstrates greater discriminatory power than the WBH model in predicting the incidence of CIN. Mortality was significantly higher in patients who developed CIN after PCI.

Surgical Versus Percutaneous Femoral Access for Delivery of Large-Bore Cardiovascular Devices (from the PARTNER Trial).

It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.

Usefulness and safety of ultrasound-assisted catheter-directed thrombolysis for submassive pulmonary emboli.

The optimal treatment for intermediate-risk pulmonary embolism (PE) remains unclear. Our goal was to describe the safety and efficacy of the EkoSonic ultrasound-assisted catheter-directed thrombolysis system (EKOS Corporation, Bothell, Washington) in a real-world registry of patients with intermediate-risk PE. Fifty-three consecutive patients with intermediate-risk PE treated with ultrasound-assisted catheter-directed thrombolysis at Brigham and Women's Hospital from 2010 to 2014 were analyzed. The primary outcome was a change in directly measured pulmonary artery pressures as assessed using logistic regression with generalized estimating equations to account for serial measurements. Patients received an average of 24.6 ± 9 mg of alteplase using the EKOS catheter with an average treatment time of 15.9 ± 3 hours. After treatment, there was a 7.2- and a 11.4-mm Hg reduction in mean and systolic pulmonary artery pressure (95% confidence interval 4.7 to 9.7 mm Hg, p <0.001, and 95% confidence interval 7.8 to 15.0 mm Hg, p <0.001), respectively. In this cohort, 9.4% had any bleeding complication noted during their hospital stay. One patient's alteplase was prematurely discontinued for access site bleeding although no other interventions were required related to bleeding complications.

Changes in geographic variation in the use of percutaneous coronary intervention for stable ischemic heart disease after publication of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

BACKGROUND: Clinical uncertainty is cited as a cause of geographic variation. However, little is known about the effect of comparative effectiveness research on variation. We examined whether geographic variation in the use of percutaneous coronary intervention (PCI) for stable ischemic heart disease (SIHD) declined after publication of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial. METHODS AND RESULTS: We examined changes in utilization and geographic variation in 67 hospital referral regions using the State Inpatient Databases. We compared age- and sex-adjusted rates of PCI for SIHD before (2006) and after (2008) publication of the COURAGE trial and compared those with contemporaneous changes in PCI volume for acute coronary syndrome. A total of 272,659 PCIs for SIHD from 526 hospitals were included in the analysis. After the publication of the COURAGE trial, PCI volume for SIHD declined by 25% (P<0.001) and decreased by 12% for acute coronary syndrome (P<0.001). This was predominantly attributable to changes in hospital referral regions with the highest levels of utilization pre-COURAGE trial (35% decline in the highest tertile versus 18% in the lowest). As measured by the systematic component of variation, there was substantial geographic variation in the use of PCI for SIHD preceding the publication of the COURAGE trial. Variation declined by 28% (0.53 versus 0.40) after publication, but geographic variation remained higher for SIHD than acute coronary syndrome (0.40 versus 0.17). CONCLUSIONS: There was a substantial decline in the use of and geographic variation in PCI for SIHD after the publication of the COURAGE trial. However, geographic variation in the use of PCI for SIHD remained high.

Incidence and implications of idiopathic thrombocytopenia following transcatheter aortic valve replacement with the Edwards Sapien(©) valves: a single center experience.

OBJECTIVES: To determine the incidence and etiology of thrombocytopenia following transcatheter Aortic valve replacement (TAVR). BACKGROUND: the use of TAVR in the United States has grown rapidly. Anecdotally, thrombocytopenia following TAVR with the Sapien valves has been observed, though little is known about this phenomenon. METHODS: All patients treated with TAVR using a Sapien valve or who underwent isolated balloon aortic valvuloplasty (BAV) at Brigham and Women's Hospital from October 2009 through November 2012 were analyzed. Post-procedure thrombocytopenia severity was stratified as none (>150,000 cells/µL), mild (100-150,000), and moderate to severe (<100,000). Summary statistics and simple comparisons were evaluated. Linear regression models were used to identify patient or procedural factors associated with platelet count nadir. RESULTS: 112 TAVR and 105 BAV patients were analyzed. Following TAVR the prevalence of thrombocytopenia was 69% and the incidence of new thrombocytopenia was 45% compared to 37% and 17% respectively following BAV (P < 0.01). Similar results were found across all strata of thrombocytopenia severity. Post-TAVR platelet nadirs were greater by 1,840 cells/µL for each 1% increase in STS score (P = 0.03) and 670 cells/µL greater for each 1 mmHg increase in pre-TAVR mean aortic stenosis gradient. Among TAVR patients, thrombocytopenia appears to spontaneously resolve an average of 8 days post-procedure. No differences in clinical outcomes based on thrombocytopenia severity were observed except for an increased use of blood products (P = 0.05). CONCLUSIONS: Thrombocytopenia following TAVR with the Edwards' Sapien valves is a frequent but generally self-limited process. The etiology of this phenomenon is unknown.

Transcatheter aortic valve replacement using the Edwards SAPIEN transcatheter heart valves.

Transcatheter aortic valve replacement has a place in the therapy for valvular aortic stenosis in a selected population of patients with increased risk for standard aortic valve replacement. The SAPIEN family of balloon-expandable transcatheter heart valves is the prototype that initiated this therapy and has undergone rapid development and evolution. The SAPIEN system has taught cardiologists and cardiac surgeons much about the nature of aortic stenosis and the potential for less invasive therapy. This article will review the SAPIEN transcatheter heart valves and the clinical experience.

Racial differences in rates of aortic valve replacement in patients with severe aortic stenosis.

Racial disparities exist in the treatment of many cardiovascular diseases. Aortic valve replacement (AVR) is the only treatment for aortic stenosis (AS) that improves patient symptoms and survival. To date, no studies have compared the rate of AVR among different races. The records of patients with an aortic valve area <1 cm(2) by echocardiography diagnosed between January 2004 and May 2010 at Barnes-Jewish Hospital were reviewed retrospectively. Patients were stratified by race. Of the 880 patients analyzed, 10% were African American (AA), and 90% were European American (EA). AA more frequently had hypertension (82% vs 67%, p <0.01), diabetes mellitus (45% vs 32%, p = 0.02), chronic kidney disease (28% vs 17%, p = 0.01), and end stage renal disease (18% vs 2%, p <0.001). AA underwent AVR less frequently than EA (39% vs 53%, p = 0.02) and refused intervention more often (33% vs 20%, p = 0.04). When treated, AA and EA had similar 3-year survival (49% [38 to 60] vs 50% [45 to 54], p = 0.31). Identification of the factors associated with treatment refusal would further our ability to counsel patients on the decision to pursue AVR.

Adjunctive Pharmacotherapy for Thrombotic Coronary Lesions.

Patients with unstable coronary syndromes are often found to have intracoronary thrombus on angiography. Despite advancements in catheter-based treatments for coronary disease, these lesions remain challenging, as percutaneous coronary intervention of thrombus-containing lesions may be associated with worse outcomes. This article reviews the literature on adjunctive pharmacotherapy in the treatment of thrombotic coronary lesions with special focus on ST-segment elevation myocardial infarction, lesions with high thrombus burden, and saphenous vein graft intervention.

Recommendations for management of antiplatelet therapy in patients undergoing elective noncardiac surgery after coronary stent implantation.

Patients commonly undergo noncardiac surgical procedures after implantation of a coronary stent. In the case where surgery cannot be deferred until completing the minimum duration of dual antiplatelet therapy, the Brigham and Women's Hospital Cardiac Catheterization Laboratory recommends using a glycoprotein IIb/IIIa bridging protocol to minimize the risk of perioperative ischemic events. We discuss our algorithm for managing antiplatelet agents, including the newer agents, prasugrel and ticagrelor, in patients undergoing noncardiac surgery after coronary stenting and present our glycoprotein IIb/IIIa bridging strategy along with a review of the relevant pharmacodynamic and clinical evidence.

Trends in smoking cessation counseling: experience from American Heart Association-get with the guidelines.

BACKGROUND: Successful smoking cessation in stroke and coronary artery disease (CAD) patients is important, as smoking contributes to significant morbidity and mortality. The American Heart Association developed Get With The Guidelines (GWTG) to improve compliance with national guideline recommendations for cardiovascular care. Using data from GWTG, we examined trends associated with the smoking-cessation counseling (SCC) performance measure. HYPOTHESIS: Implementation of a systematic quality improvement program will increase compliance with the SCC performance measure. METHODS: We evaluated compliance with SCC in current or recent smokers identified from 224 671 CAD admissions between 2002 and 2008 in the GWTG-CAD database, and from 405 681 stroke admissions between 2002 and 2007 in the GWTG-Stroke database. Additionally, we examined adherence to other performance and quality measures related to CAD and stroke care. RESULTS: Overall, 55 904 GWTG-CAD and 58 865 GWTG-Stroke admissions were used for the analysis. Rates of SCC improved in each successive year during the study, from 67.6% to 97.4% (P < 0.001) in GWTG-CAD and from 40.1% to 90.7% (P < 0.001) in GWTG-Stroke. Compliance with SCC was up to 34.7% lower (P < 0.0001) in GWTG-Stroke compared with GWTG-CAD, but this difference decreased to 6.7% (P < 0.0001) by the end of the study period. Compliance with many other performance and quality measures was significantly lower among patients not receiving SCC. CONCLUSIONS: Get With The Guidelines has improved compliance with the SCC performance measure among patients with CAD and stroke. Although the initial disparity in rates of SCC between CAD and stroke patients gradually improved, the difference remained significant.

Two-year clinical outcomes with paclitaxel-eluting coronary stents in patients with chronic total occlusions: analysis from the TAXUS ARRIVE program.

AIMS: To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) in chronic total occlusions (CTO) in an unselected patient population. METHODS AND RESULTS: The TAXUS ARRIVE registries compiled data on 7,492 patients, including 113 patients with CTO (TIMI flow 0). Patients enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent end-point adjudication. Two-year follow-up was 89% (101/113) for CTO patients who had significantly more baseline comorbidities/complex disease than simple-use patients undergoing native coronary intervention (N = 2,698) and significantly longer lesions/smaller vessels than other expanded-use patients (N = 4,681 without CTO). Among CTO patients the rate of 2-year major cardiac events (MCE, including cardiac death, myocardial infarction, and target vessel revascularization) was 22.3%, significantly higher than in simple-use patients (10.3%, P < 0.001). CTO MCE was similar to that for other expanded-use patients (16.5%, P = 0.14) but target lesion revascularization was significantly higher in year 2 (6.9% vs. 2.7%, P = 0.02). Academic Research Consortium definite/probable stent thrombosis through 2 years was 5.7%, significantly higher than simple-use patients but similar to other expanded-use cases. CONCLUSION: In a "real-world" setting, PES use in CTO was associated with increased MCE compared to simple- use patients, but achieved long-term outcomes similar to that observed in other complex patient/lesion cases.

Transthoracic echocardiographic assessment of continuous-flow left ventricular assist devices.

An increasing number of patients are implanted with continuous-flow left ventricular assist devices (LVAD) for the treatment of severe congestive heart failure. In parallel with this growing experience has been an increase in knowledge of how these devices alter cardiac physiology and the important implications this has for cardiac function. Echocardiography offers the ability to provide serial noninvasive evaluation before and after LVAD implantation to document these changes, guide management decisions, and identify LVAD dysfunction. The authors detail a comprehensive assessment of LVAD function by transthoracic echocardiography.